Genomtec has obtained the CE-IVD mark for its flagship solution, the Genomtec®ID Respiratory Panel 5-Plex (RP5-PLEX) diagnostic panel for the detection of pathogens causing respiratory diseases. This is the only diagnostic panel of its kind that simultaneously tests for the presence of as many as 5 viruses and bacteria in the same test and which, thanks to CE-IVD certification, will be available for sale in 27 European Union countries as well as in Iceland, Norway and Liechtenstein. Thus, Genomtec has realized the most important stage in the Company’s development so far, fulfilling the promises made to investors.
CE-marking is required for all in vitro diagnostic (IVD) devices to be placed on the market in countries of the European Economic Area (EEA) and Iceland, Norway and Liechtenstein, and means that the device can be legally sold in these areas and that its standard is in accordance with the directive on in vitro diagnostics (98/79/EC).
The Genomtec®ID RP5-PLEX diagnostic panel simultaneously detects the presence of Influenza A and B viruses, RSV (Respiratory Syncytial Virus), SARS-CoV-2 and the atypical bacteria Mycoplasma pneumoniae and Chlamydophila pneumoniae. The Genomtec® ID Analyzer, with which a reaction card (panel) is used along with a sample from a patient to perform a genetic test, is one of the smallest portable genetic laboratories in the world.
– I am very proud to register and assign CE-IVD mark for our first POCT product that enables rapid genetic testing targeting respiratory tract infections . Genomtec was founded in 2016 and we have worked hard to realize our plans. I would like to thank my team for their tireless work, brilliant ideas and commitment as well as investors that since 2016 are continuously trust that the pathway we are heading is the right one. We are excited to move to the main part of the commercialisation stage focused expanding the network of distributors , validating our invention with early customers and preparing to start scalable production – said Miron Tokarski, co-founder and CEO of Genomtec.
The company will now work to acquire as many distributors in Europe as possible, optimize the cost of manufacturing of the analyser and reaction cards, and prepare for scalable production of its flagship solution.
– We have just signed a distribution agreement in Greece and are working on further commercial agreements. By the end of the year, we hope to have early feedback on the device by our partners, which will be very valuable. We will also optimize the cost of manufacturing the solution by working with new, larger partners. We will consider what new solutions we should work on in the next stages of the Company’s development. I am very pleased that we have reached such an important regulatory milestone as registration in the European Union and obtaining CE-IVD Certification. Now, an exciting new chapter begins for us – said Charudutt Shah, Chief Business Officer with Genomtec.